The following data is part of a premarket notification filed by Dentovations, Inc. with the FDA for South Beach Smile Light Whitening System.
| Device ID | K042153 |
| 510k Number | K042153 |
| Device Name: | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | DENTOVATIONS, INC. 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich DENTOVATIONS, INC. 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-11-08 |
| Summary: | summary |